BISOPROLOL ZENTIVA 1.25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bisoprolol Zentiva 1.25mg tablets EFG

Bisoprolol Zentiva 2.5mg tablets EFG

Bisoprolol Zentiva 5mg tablets EFG

Bisoprolol Zentiva 10mg tablets EFG

bisoprolol fumarate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Bisoprolol Zentiva and what is it used for
2. What you need to know before you take Bisoprolol Zentiva
3. How to take Bisoprolol Zentiva
4. Possible side effects
5. Storage of Bisoprolol Zentiva
6. Pack contents and further information

1. What is Bisoprolol Zentiva and what is it used for

The active substance of this medicine is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines affect the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient, pumping blood throughout the body. At the same time, it reduces the heart's need for blood and oxygen.

This medicine is used to treat stable chronic heart failure. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. It is used in combination with other suitable medicines for this condition (such as ACE inhibitors, diuretics, and cardiac glycosides).

In addition, bisoprolol 5 mg and 10 mg are used to treat high blood pressure (hypertension) and chest pain due to reduced blood flow to the coronary arteries (ischemic heart disease: angina pectoris).

2. What you need to know before you take Bisoprolol Zentiva

Do not take this medicine

• if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe asthma;
• if you have a late-stage vascular disease that impairs blood flow to the arms and legs (peripheral arterial occlusive disease);
• if you have severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or turn them pale or blue;
• if you have an untreated pheochromocytoma (a rare tumor of the adrenal gland);
• if you have metabolic acidosis (a condition that occurs when there is too much acid in the blood).

Do not take this medicine if you have any of the following heart problems:

• acute heart failure;
• worsening of heart failure that requires intravenous injection of medicines that increase the heart's contractile force;
• slow heart rate (less than 50 bpm);
• low blood pressure (systolic less than 90 mmHg);
• certain heart conditions that cause a very slow or irregular heart rate;
• cardiogenic shock (a severe and acute heart disease that causes a drop in blood pressure and circulatory failure).

If you think any of the above problems apply to you, consult your doctor about taking this medicine.

Warnings and precautions

If you have any of the following problems, consult your doctor or pharmacist before taking this medicine. They may want to take special precautions (such as providing additional treatment or performing more frequent tests):

• diabetes;
• strict fasting;
• certain heart diseases such as arrhythmias or severe chest pain at rest (Prinzmetal's angina);
• kidney or liver problems;
• less severe circulatory problems in the limbs;
• chronic lung disease or less severe asthma;
• history of scaly skin rash (psoriasis);
• adrenal gland tumor (pheochromocytoma);
• thyroid disorder.

In addition, inform your doctor if you are going to undergo:

• desensitization treatment (e.g., to prevent hay fever), as this medicine may make you more likely to experience an allergic reaction, or such a reaction may be more severe;
• anesthesia (e.g., for surgery), as this medicine may affect how your body reacts to this situation.

If you have chronic lung disease or less severe asthma, inform your doctor immediately if you start to notice breathing difficulties, coughing, wheezing after exercise, etc. while using this medicine.

Children and adolescents

The use of this medicine is not recommended in children or adolescents.

Other medicines and Bisoprolol Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take the following medicines with bisoprolol without special advice from your doctor:

• certain medicines used to treat irregular or abnormal heartbeats (class I antiarrhythmic medicines such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, or propafenone);
• certain medicines used to treat high blood pressure, angina pectoris, or irregular heartbeat (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, or rilmenidine. However, do not stop taking these medicineswithout consulting your doctor first.

Consult your doctor before taking the following medicines with bisoprolol; your doctor may need to monitor your condition more frequently:

• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as felodipine and amlodipine);
• certain medicines used to treat irregular or abnormal heartbeats (class III antiarrhythmic medicines such as amiodarone);
• locally applied beta-blockers (such as eye drops containing timolol for glaucoma treatment);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics such as tacrine or carbachol) or medicines used to treat acute heart problems (sympathomimetics such as isoprenaline, dobutamine, and orciprenaline);
• antidiabetic medicines, including insulin;
• anesthetic agents (e.g., during surgery);
• digitalis, used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain, or inflammation (e.g., ibuprofen or diclofenac);
• any medicine that may lower blood pressure as a desired or undesired effect, such as antihypertensives, certain medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat epilepsy or during anesthesia (barbiturates such as phenobarbital), or certain medicines for treating mental illnesses characterized by loss of contact with reality (phenothiazines such as levomepromazine);
• mefloquine, used for the prevention or treatment of malaria;
• medicines for treating depression called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.

Pregnancy

There is a risk that the use of bisoprolol during pregnancy may harm the baby. If you are pregnant or plan to become pregnant, inform your doctor. Your doctor will decide whether you can take bisoprolol during pregnancy.

Breastfeeding

It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during treatment with this medicine.

Driving and using machines

Your ability to drive or use machines may be affected depending on how well you tolerate the medicine. Be especially careful at the start of treatment, when the dose is increased, or the medication is changed, and also in combination with alcohol.

3. How to take Bisoprolol Zentiva

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Treatment with bisoprolol requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during dose increase, and when stopping treatment.

Take the tablet with a little water in the morning, with or without food. Do not crush or chew the tablet. The score line is not intended to break the tablet.

Treatment with bisoprolol is usually long-term.

Chronic heart failure

Adults, including the elderly

Treatment with bisoprolol should be started at a low dose and gradually increased. Your doctor will decide how to increase the dose, and this will usually be done as follows:

• 1.25 mg of bisoprolol once daily for one week
• 2.5 mg of bisoprolol once daily for one week
• 3.75 mg of bisoprolol once daily for one week
• 5 mg of bisoprolol once daily for four weeks
• 7.5 mg of bisoprolol once daily for four weeks
• 10 mg of bisoprolol once daily as maintenance therapy (continuing).

The maximum recommended daily dose is 10 mg of bisoprolol.

In case Bisoprolol Zentiva 1.25 mg, 3.75 mg, or 7.5 mg is not marketed in your country, the doses can be achieved with other bisoprolol products available.

Depending on how well you tolerate the medicine, your doctor may also decide to prolong the time between dose increases. If your condition worsens or you no longer tolerate the medicine, it may be necessary to reduce the dose again or stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient. Your doctor will tell you what to do.

Normally, if you need to stop treatment completely, your doctor will advise you to gradually reduce the dose, as otherwise, your condition may worsen.

High blood pressure (hypertension)

Adults, including the elderly

Unless otherwise indicated, the recommended dose of bisoprolol is 5 mg daily. In the case of mild elevation of blood pressure (diastolic blood pressure up to 105 mmHg), treatment with 2.5 mg once daily may be sufficient, using other medicines at the appropriate dose.

If the effect is insufficient, the dose can be increased to 10 mg of bisoprolol daily. Further dose increase is only justified in exceptional cases.

The maximum recommended dose is 20 mg once daily.

Ischemic heart disease (angina pectoris)

Adults, including the elderly

Unless otherwise indicated, the recommended dose of bisoprolol is 5 mg daily.

If the effect is insufficient, the dose can be increased to 10 mg of bisoprolol daily. Further dose increase is only justified in exceptional cases.

The maximum recommended dose is 20 mg once daily.

High blood pressure (hypertension) and ischemic heart disease (angina pectoris)

Dosing in case of hepatic or renal impairment

In patients with mild to moderate renal or hepatic impairment, the dose does not usually need to be adjusted. In patients with severe renal impairment (creatinine clearance <20 ml min) and in patients with severe hepatic impairment, the daily dose should not exceed 10 mg of bisoprolol fumarate.< p>

If you take more Bisoprolol Zentiva than you should

If you have taken more tablets of this medicine than you should, inform your doctor immediately. Your doctor will decide what actions are necessary.

The symptoms of an overdose include slow heart rate, severe breathing difficulties, dizziness, or tremors (due to low blood sugar).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bisoprolol Zentiva

Do not take a double dose to make up for forgotten doses. Take your usual dose the next morning.

If you stop taking Bisoprolol Zentiva

Never stop taking this medicine except on medical advice. Otherwise, your condition could worsen significantly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

To prevent serious side effects, talk to a doctor immediately if a side effect is severe, occurs suddenly, or worsens rapidly.

The most serious side effects are related to heart function:

• slow heart rate (may affect more than 1 in 10 people with chronic heart failure; may affect up to 1 in 100 people with hypertension or angina pectoris);
• worsening of heart failure (may affect up to 1 in 10 people);
• slow or irregular heartbeats (may affect up to 1 in 100 people).

If you feel dizzy or weak, or have breathing difficulties, contact your doctor as soon as possible.

Below are mentioned other side effects according to their frequency of possible occurrence:

Common(may affect up to 1 in 10 people):

• fatigue*, weakness (in patients with chronic heart failure), dizziness*, headache*;
• feeling of cold or numbness in hands or feet;
• low blood pressure;
• stomach or intestinal problems such as nausea, vomiting, diarrhea, or constipation.

*These symptoms occur especially at the start of treatment. They are usually mild and tend to disappear within 1 or 2 weeks after the start of treatment.

Uncommon(may affect up to 1 in 100 people):

• feeling weak (in patients with hypertension or angina pectoris);
• sleep disturbances;
• depression;
• dizziness when standing up;
• breathing problems in patients with asthma or chronic lung disease;
• muscle weakness and muscle cramps.

Rare(may affect up to 1 in 1,000 people):

• hearing problems;
• allergic runny nose;
• reduced tear production (note this if you wear contact lenses);
• liver inflammation that can cause yellowing of the skin or the whites of the eyes;
• certain abnormal blood test results for liver function or fat levels;
• allergic reactions such as itching, redness, or skin rash. You should immediately consult your doctor if you experience more severe allergic reactions, which can include swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing.
• erectile dysfunction;
• nightmares, hallucinations;
• fainting.

Very rare(may affect up to 1 in 10,000 people):

• eye irritation and redness (conjunctivitis);
• hair loss;
• appearance or worsening of scaly skin rash (psoriasis); psoriasis-like rash.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisoprolol Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date is the last day of the month stated.

For medicines packaged in OPA/Alu/PVC100//Alu or OPA/Alu/PVC60//Alu blisters:

Store below 30°C. Store in the original packaging to protect from moisture.

For medicines packaged in white PVC/PVdC//Alu blisters:

Store below 25°C. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. If you have any further questions on the disposal of unused medicines, ask your pharmacist. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Bisoprolol Zentiva

The active ingredient is bisoprolol fumarate.

Bisoprolol 1.25 mg tablets: Each tablet contains 1.25 mg of bisoprolol fumarate.

Bisoprolol 2.5 mg tablets: Each tablet contains 2.5 mg of bisoprolol fumarate.

Bisoprolol 5 mg tablets: Each tablet contains 5 mg of bisoprolol fumarate.

Bisoprolol 10 mg tablets: Each tablet contains 10 mg of bisoprolol fumarate.

The other ingredients are microcrystalline cellulose (PH 102); pregelatinized starch (maize); crospovidone (type A); colloidal anhydrous silica and magnesium stearate.

Bisoprolol 5 mg tablets and Bisoprolol 10 mg tablets also contain yellow iron oxide (E172) and Bisoprolol 10 mg tablets also contain brown iron oxide (E172).

Appearance of Bisoprolol Zentiva and Packaging Contents

Bisoprolol 1.25 mg tablets: white, round tablets with a raised outline of 1.25 and a diameter of 6 mm ± 0.3 mm.

Bisoprolol 2.5 mg tablets: white, round tablets with a raised outline of 2.5, a score line and a diameter of 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.

Bisoprolol 5 mg tablets: yellowish to light yellow, round tablets with a raised outline of 5, a score line and a diameter of 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.

Bisoprolol 10 mg tablets: ochre, round tablets with a raised outline of 10, a score line, randomly distributed colorant spots and a diameter of 6 mm ± 0.3 mm. The score line is not intended for breaking the tablet.

Package sizes:

1.25 mg: 20, 28, 30, 60, 90 or 100 tablets

2.5 mg: 15, 28, 30, 60, 90 or 100 tablets

5 mg; 10 mg: 28, 30, 50, 56, 60, 90 or 100 tablets

Only some pack sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

For 2.5 mg, 5 mg and 10 mg:

ZENTIVA, k.s.

U kabelovny 130

102 37 Prague 10 – Dolní Mecholupy

Czech Republic

or

S.C. ZENTIVA S.A.

B-dul Theodor Pallady nr. 50, sector 3,

Bucharest, cod 032266

Romania

For 1.25 mg:

ZENTIVA, k.s.

U kabelovny 130

102 37 Prague 10 – Dolní Mecholupy

Czech Republic

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet:June 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.